Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients
NCT ID: NCT00798070
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
2017 participants
INTERVENTIONAL
2007-02-28
2028-01-31
Brief Summary
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A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second week, to
B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel (FEC→T).
Patients with primary node-positive or high risk lymph node negative breast cancer will be eligible for the study.
The primary objective of the phase 3 study is to compare breast cancer relapse-free survival (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to 0.790 about 1000 patients per arm will be needed. They will be recruited during four years and followed another two years for breast cancer events.
Secondary objectives are to compare
1. Distant disease-free survival (DDFS)
2. Event-free survival and
3. Overall survival
4. Health-related quality of life and toxicity analyses according to CTC
5. Outcome in relation to tumour biological factors and polymorphism patterns
1. RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm
2. RFS with receptor positive disease (analyzed in the local laboratories as described in the CRFs and also analyzed as continuous variables) in the comparison between the A- and B- arms.
3. RFS with high and low proliferation, respectively, (analyzed in the local laboratories as described in the CRFs and also analyzed as a continuous variable, or centrally analyzed), in the comparison between the A- and B-arms.
4. RFS in relation to HER-2/neu status (analyzed in the local laboratories as described in the CRFs) in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently.
5. RFS analyzed in relation to other molecular markers (e.g. gene expression profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA (related to toxicities for EC/FEC and docetaxel components, respectively, and given dose levels and outcome in relation to these factors and in relation QoL) to outcome per arm.
6. RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms.
Tumour tissue will be obtained and stored for studies of prognostication and therapy prediction.
Last patient randomized was September 2011.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: dtEC→dtT
Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second week
dtEC→dtT
Individually tailored and two weekly dosed epirubicin (start dose 90mg/m2) + cyclophosphamide (start dose 600mg/m2) followed by a three weeks break followed by biweekly and tailored docetaxel (start dose 75mg/m2) given every second week. If toxicity measured by CTC-NCI criteria are grade 2 or less (except haematological toxicity) it will be possible to escalate doses
Arm B: FEC→T
Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel
FEC→T
Fixed dosed and three weekly epirubicin (100mg/m2), cyclophosphamide (500mg/m2) and 5-fluorouracil (500mg/m2), followed by fixed dosed and three weekly docetaxel (100mg/m2), no dose escalations.
Interventions
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dtEC→dtT
Individually tailored and two weekly dosed epirubicin (start dose 90mg/m2) + cyclophosphamide (start dose 600mg/m2) followed by a three weeks break followed by biweekly and tailored docetaxel (start dose 75mg/m2) given every second week. If toxicity measured by CTC-NCI criteria are grade 2 or less (except haematological toxicity) it will be possible to escalate doses
FEC→T
Fixed dosed and three weekly epirubicin (100mg/m2), cyclophosphamide (500mg/m2) and 5-fluorouracil (500mg/m2), followed by fixed dosed and three weekly docetaxel (100mg/m2), no dose escalations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receptor negative or positive tumours with 1 or more positive axillary lymph nodes (more than 0.2 mm) OR axillary node negative breast cancers if the primary tumour is larger than 20 mm and receptor negative (Er and Pgr with no receptor content) and being Elston grade III. In Germany high risk node negative breast cancer patients are not eligible until labelling for docetaxel includes node-negative disease.
* A primary breast cancer patient being 35 years or younger considered suitable for adjuvant chemotherapy (may be receptor negative or positive, HER-2/neu negative or positive, with or without axillary lymph node metastases).
* Macroscopically and microscopically free margins after radical surgery (no cancer cells at borders of resection).
* No proven distant metastases (negative chest/pulmonary X-ray, bone scintigram (when clinical signs of skeletal metastases or elevated ALP) supplemented with normal conventional X-ray of hot spots, normal liver function test and haematological function tests; when abnormal values, CT or ultrasound of the liver, patient can be included if no metastases are demonstrated.
* Female age 18-65.
* Ambulant patients (ECOG 1 or less).
* No major cardiovascular morbidity NYHA I or II. (Appendix 3).
* Written informed consent according to the local ethics committee requirements.
* Patients of childbearing potential should have a negative pregnancy test within seven days of registration. (In Austria, pregnancy tests have to be repeated monthly during the treatment phase).
Exclusion Criteria
* Non-radical surgery (histopathological positive margins).
* Proven distant metastases.
* Pregnancy or lactation.
* Other serious medical condition.
* Previous or concurrent malignancies at other sites, except basal cell carcinoma and/or squamous cell carcinoma in situ of the skin or cervix. Patients with previous breast cancer (invasive and/or ductal carcinoma in situ) in the other breast without loco-regional (large lung volumes) radiotherapy, without objective findings for relapse, with \> 5 years since diagnosis can be included.
* Abnormal laboratory values precluding the possibility to safely deliver the used cytotoxic agents in the study.
* Hypersensitivity to drugs formulated in polysorbate 80.
* Peripheral neuropathy grade ≥2.
18 Years
65 Years
FEMALE
No
Sponsors
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Swedish Breast Cancer Group
OTHER
Austrian Breast & Colorectal Cancer Study Group
NETWORK
GBG Forschungs GmbH
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Prof Jonas Bergh
MD, PhD
Principal Investigators
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Jonas Bergh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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MUG - Med. Univ.-Klinik Graz
Graz, , Austria
MUI - Univ. Klinik f. Frauenheilkunde, Innsbruck
Innsbruck, , Austria
LKH Leoben
Leoben, , Austria
AKH Linz
Linz, , Austria
KH BHS Linz
Linz, , Austria
LKH Rankweil
Rankweil, , Austria
KH BHB St. Veit/Glan
Saint Veit/Glan, , Austria
LKH Salzburg / PMU
Salzburg, , Austria
Brustzentrum Hanusch-KH
Vienna, , Austria
Klinikum Wels - Grieskirchen GmbH
Wels, , Austria
Marienhospital
Aachen, , Germany
Klinikum am Bruderwald
Bamberg, , Germany
Klinikum Bayreuth
Bayreuth, , Germany
HELIOS Klinikum
Berlin, , Germany
Klinikum Bietigheim
Bietigheim, , Germany
Johanniter Krankenhaus
Bonn, , Germany
Universitätsfrauenklinik
Bonn, , Germany
Klinikum Sindelfingen-Böblingen
Böblingen, , Germany
Krankenhaus Celle
Celle, , Germany
St. Elisabeth-KKH
Cologne, , Germany
Klinikum Deggendorf
Deggendorf, , Germany
Diakonissen Krankenhaus
Dresden, , Germany
Gemeinschaftspraxis
Dresden, , Germany
Krankenhaus St. Joseph-Stift
Dresden, , Germany
Praxis Dr. Adhami
Erkelenz, , Germany
Klinikum der J. W. Goethe Universität
Frankfurt am Main, , Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, , Germany
Onkologische Gemeinschaftspraxis
Frankfurt am Main, , Germany
Kreiskrankenhaus
Freudenstadt, , Germany
Klinikum Fulda
Fulda, , Germany
Onkologische Schwerpunktpraxis
Goslar, , Germany
Krankenhaus St. Elisabeth und St. Barbara
Halle, , Germany
Universitätsfrauenklinik
Halle, , Germany
Klinikum Hameln
Hamelin, , Germany
Henriettenstiftung
Hanover, , Germany
Medizinische Hochschule
Hanover, , Germany
Universität Heidelberg
Heidelberg, , Germany
Klinikum Heilbronn
Heilbronn, , Germany
Gemienschaftspraxis
Hildesheim, , Germany
Universitätsfrauenklinik
Homburg, , Germany
St. Vincentius Kliniken
Karlsruhe, , Germany
Städtisches Klinikum
Karlsruhe, , Germany
Elisabeth Krankenhaus
Kassel, , Germany
Klinikum Kempten
Kempten, , Germany
St. Vincenz Krankenhaus
Limburg, , Germany
Onkologische Tagesklinik
Lohsa, , Germany
Klinikum Ludwigsburg
Ludwigsburg, , Germany
Ev. Krankenhaus
Ludwigsfelde, , Germany
St. Vincenz und Elisabeth-Hospital
Mainz, , Germany
Universitätsfrauenklinik
Mainz, , Germany
Universitätsfrauenklinik
Mannheim, , Germany
Klinikum Fichtelgebirge
Marktredwitz, , Germany
Onkologische Praxis
Memmingen, , Germany
Gemeinschaftspraxis Münster
Münster, , Germany
Praxis am Klinikum Neumarkt
Neumarkt, , Germany
Onkologische Praxis
Pinneberg, , Germany
Klinikum am Steinenberg
Reutlingen, , Germany
Klinikum Rheinfelden
Rheinfelden, , Germany
Klinikum Schwerin
Schwerin, , Germany
Gesellschaft für onkologische Studien
Troisdorf, , Germany
Klinikum Tuttlingen
Tuttlingen, , Germany
Universitätsfrauenklinik
Tübingen, , Germany
Universitätsfrauenklinik
Ulm, , Germany
Klinikum Villingen-Schwenningen
Villingen, , Germany
Klinikum Weiden
Weiden, , Germany
Klinikum Weinheim
Weinheim, , Germany
Asklepios Paulinen Klinik
Wiesbaden, , Germany
St. Josefs-Hospital
Wiesbaden, , Germany
Stadtkrankenhaus
Worms, , Germany
Central Hospital
Gävle, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Central Hospital
Karlstad, , Sweden
Linköping University Hospital
Linköping, , Sweden
Lund University Hospital
Lund, , Sweden
Malmö General University Hospital
Malmo, , Sweden
Örebro University Hospital
Örebro, , Sweden
Karolinska University Hospital, Dept of Oncology
Stockholm, , Sweden
Central Hospital
Sundsvall, , Sweden
Norrlands University Hospital
Umeå, , Sweden
Uppsala Academic Hospital
Uppsala, , Sweden
Countries
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References
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Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019 Apr 6;393(10179):1440-1452. doi: 10.1016/S0140-6736(18)33137-4. Epub 2019 Feb 8.
Matikas A, Papakonstantinou A, Loibl S, Steger GG, Untch M, Johansson H, Tsiknakis N, Hellstrom M, Greil R, Mobus V, Gnant M, Bergh J, Foukakis T. Benefit from dose-dense adjuvant chemotherapy for breast cancer: subgroup analyses from the randomised phase 3 PANTHER trial. Lancet Reg Health Eur. 2024 Dec 3;49:101162. doi: 10.1016/j.lanepe.2024.101162. eCollection 2025 Feb.
Matikas A, Mobus V, Greil R, Andersson A, Steger GG, Untch M, Fornander T, Malmstrom P, Schmatloch S, Johansson H, Hellstrom M, Brandberg Y, Gnant M, Loibl S, Foukakis T, Bergh J; SweBCG, ABCSG and GBG. Tailored Dose-Dense Versus Standard Adjuvant Chemotherapy for High-Risk Early Breast Cancer: End-of-Study Results of the Randomized PANTHER Trial. J Clin Oncol. 2024 Sep 10;42(26):3077-3082. doi: 10.1200/JCO.24.00178. Epub 2024 Jul 17.
Zerdes I, Simonetti M, Matikas A, Harbers L, Acs B, Boyaci C, Zhang N, Salgkamis D, Agartz S, Moreno-Ruiz P, Bai Y, Rimm DL, Hartman J, Mezheyeuski A, Bergh J, Crosetto N, Foukakis T. Interplay between copy number alterations and immune profiles in the early breast cancer Scandinavian Breast Group 2004-1 randomized phase II trial: results from a feasibility study. NPJ Breast Cancer. 2021 Nov 19;7(1):144. doi: 10.1038/s41523-021-00352-3.
Brandberg Y, Johansson H, Hellstrom M, Gnant M, Mobus V, Greil R, Foukakis T, Bergh J; Swedish Breast Cancer Group, the Austrian Breast, Colorectal Cancer Study Group, the German Breast Cancer Group. Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer. Breast Cancer Res Treat. 2020 May;181(1):87-96. doi: 10.1007/s10549-020-05602-9. Epub 2020 Mar 31.
Papakonstantinou A, Matikas A, Bengtsson NO, Malmstrom P, Hedayati E, Steger G, Untch M, Hubbert L, Johansson H, Hellstrom M, Gnant M, Loibl S, Greil R, Moebus V, Foukakis T, Bergh J. Efficacy and safety of tailored and dose-dense adjuvant chemotherapy and trastuzumab for resected HER2-positive breast cancer: Results from the phase 3 PANTHER trial. Cancer. 2020 Mar 15;126(6):1175-1182. doi: 10.1002/cncr.32653. Epub 2019 Dec 18.
Papakonstantinou A, Hedayati E, Hellstrom M, Johansson H, Gnant M, Steger G, Greil R, Untch M, Moebus V, Loibl S, Foukakis T, Bergh J, Matikas A. Neutropenic complications in the PANTHER phase III study of adjuvant tailored dose-dense chemotherapy in early breast cancer. Acta Oncol. 2020 Jan;59(1):75-81. doi: 10.1080/0284186X.2019.1670353. Epub 2019 Oct 4.
Matikas A, Foukakis T, Moebus V, Greil R, Bengtsson NO, Steger GG, Untch M, Johansson H, Hellstrom M, Malmstrom P, Gnant M, Loibl S, Bergh J. Dose tailoring of adjuvant chemotherapy for breast cancer based on hematologic toxicities: further results from the prospective PANTHER study with focus on obese patients. Ann Oncol. 2019 Jan 1;30(1):109-114. doi: 10.1093/annonc/mdy475.
Matikas A, Margolin S, Hellstrom M, Johansson H, Bengtsson NO, Karlsson L, Edlund P, Karlsson P, Lidbrink E, Linderholm B, Lindman H, Malmstrom P, Villman K, Foukakis T, Bergh J. Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer. Breast Cancer Res Treat. 2018 Apr;168(2):349-355. doi: 10.1007/s10549-017-4599-4. Epub 2017 Nov 30.
Foukakis T, von Minckwitz G, Bengtsson NO, Brandberg Y, Wallberg B, Fornander T, Mlineritsch B, Schmatloch S, Singer CF, Steger G, Egle D, Karlsson E, Carlsson L, Loibl S, Untch M, Hellstrom M, Johansson H, Anderson H, Malmstrom P, Gnant M, Greil R, Mobus V, Bergh J; Swedish Breast Cancer Group (SweBCG), the German Breast Group (GBG), and the Austrian Breast & Colorectal Cancer Study Group (ABCSG). Effect of Tailored Dose-Dense Chemotherapy vs Standard 3-Weekly Adjuvant Chemotherapy on Recurrence-Free Survival Among Women With High-Risk Early Breast Cancer: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1888-1896. doi: 10.1001/jama.2016.15865.
Bergh J. Oral presentation, ASCO Annual Meeting 2016.
Margolin S, Bengtsson NO, Carlsson L, Edlund P, Hellstrom M, Karlsson P, Lidbrink E, Linderholm B, Lindman H, Malmstrom P, Pettersson Skold D, Soderberg M, Villman K, Bergh J; Scandinavian Breast Group Study SBG 2004-1. A randomised feasibility/phase II study (SBG 2004-1) with dose-dense/tailored epirubicin, cyclophoshamide (EC) followed by docetaxel (T) or fixed dosed dose-dense EC/T versus T, doxorubicin and C (TAC) in node-positive breast cancer. Acta Oncol. 2011 Jan;50(1):35-41. doi: 10.3109/0284186X.2010.535847.
Other Identifiers
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2007-002061-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISRCTN39017665
Identifier Type: REGISTRY
Identifier Source: secondary_id
ABCSG25
Identifier Type: OTHER
Identifier Source: secondary_id
GBG53
Identifier Type: OTHER
Identifier Source: secondary_id
PANTHER SBG2004-1
Identifier Type: -
Identifier Source: org_study_id